Modafinil in Cancer Related Fatigue (ModCRF)

This study has been completed.

Sponsor:

Indira Gandhi Medical College

ClinicalTrials.gov Identifier:

NCT01440621

First Posted: September 26, 2011

Last Update Posted: March 23, 2012

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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Cancer related fatigue (CRF) is a highly prevalent and highly significant entity among patients with cancer. 'Cancer related fatigue' is not a simple symptom, but is an entity in itself, in that it is different from routine fatigue. Cancer related fatigue is that fatigue which persists even after rest and has significant effects on quality of life.

The incidence of Cancer Related Fatigue (CRF) increases during radiation therapy (RT), with almost every patient on radiotherapy complaining of at-least some magnitude of fatigue.

Given that fatigue can affect treatment adherence by patients, it is important to initiate measures to either prevent or mitigate Cancer Related Fatigue.

The investigators intend to use modafinil in cancer related fatigue, in view of the fact that it has safety and efficacy in other diseases such as narcolepsy, multiple sclerosis and fibromyalgia. In addition, there have been a few small trials which have hinted towards benefit with the use of modafinil in cancer related fatigue.

The investigators have chosen a dose of 100mg/day in the morning, to be compared with placebo. The study arm and the placebo arm will be stratified with respect to age, sex, disease site, baseline performance status.

Primary outcome would be fatigue, which will be assessed by the use of Brief Fatigue Inventory (BFI). Secondary outcomes include Quality of Life, improvements in performance status, changes in systolic and diastolic blood pressure, and changes in weight.

Will be treated with Tab Modafinil (generic) 100mg Once a Day in the Morning starting from Day 1 of RT till the first follow-up.

Drug: Modafinil

Tablet Modafinil 100mg (Generic) to be given in 100mg once a day dose, at 8AM daily in the morning, and to be given from Day 1 of Radiation Therapy till the first post treatment follow-up

Placebo Comparator: Arm P

Will be given placebo (Tab Pyridoxine 10mg) which physically resembles Tab Modafinil 100mg.

Drug: Pyridoxine

Tablet Pyridoxine 10mg once a day at 8AM daily, from Day one of RT till first post-treatment followup. Tab Pyridoxine 10mg has been chosen as placebo as it resembles Tab Modafinil 100mg in physical appearance, size and shape. Tab Pyridoxine is unlikely to affect Cancer Related Fatigue on its own as all patients on RT are already on multivitamin supplements as per our institutional guidelines.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

18 Years to 70 Years (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Patients with pathological confirmation of cancer

Age 18 years to 70 years

Performance status (Karnofsky scale) not less than 60

Providing consent

Exclusion Criteria:

Psychiatric illness

Hypertension

Diabetes

Thyroid disorders

Epilepsy

Tuberculosis

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01440621